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BMS-214662 in Treating Patients With Solid Tumors
This study has been completed.
Study NCT00005973   Information provided by National Cancer Institute (NCI)
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes

July 5, 2000
July 23, 2008
December 2000
 
 
 
Complete list of historical versions of study NCT00005973 on ClinicalTrials.gov Archive Site
 
 
 
BMS-214662 in Treating Patients With Solid Tumors
Phase I Study of Farnesyl Transferase Inhibitor BMS-214662 (NSC7100860) in Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of BMS-214662 in treating patients who have solid tumors.

OBJECTIVES:

  • Determine the maximum tolerated dose of BMS-214662 in patients with solid tumors.
  • Evaluate intermediate biological endpoints as surrogates for the effectiveness of this drug in these patients.
  • Determine the nature of dose limiting toxicity of this drug in this patient population.
  • Determine the recommended phase II regimen of this drug in these patients.
  • Establish a pharmacologic and pharmacokinetic profile of this drug in these patients.

OUTLINE: This is a dose escalation study.

Patients receive BMS-214662 IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities.

Patients are followed every 3 months for at least 24 months.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Phase I
Interventional
Treatment
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
Drug: BMS-214662
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Diagnosis of malignant solid tumor for which a standard curative therapy does not exist

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 6 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10.0 g/dL

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • AST no greater than 2 times upper limit of normal
  • Albumin at least 3.0 g/dL

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No uncontrolled heart disease
  • No history of clinically significant cardiac arrhythmia that could be exacerbated by QT interval prolongation
  • Corrected QT interval no greater than 450 milliseconds

Gastrointestinal:

  • Must not require total parenteral nutrition
  • No manifestations of malabsorption syndrome due to prior surgery, gastrointestinal disease, or unknown reasons

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No signs or symptoms of acute infection requiring systemic therapy
  • No grade 3 or 4 neurotoxicity from prior anticancer treatment or neuropathy from any cause
  • No confusion, disorientation, or psychiatric illness that may preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No more than 3 prior chemotherapy regimens
  • At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin) and recovered
  • No other concurrent antineoplastic agents

Endocrine therapy:

  • No concurrent hormonal anticancer therapy

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • Prior drugs known to prolong the QT interval allowed if they can be safely discontinued for a time period equal to 4 elimination half-lives prior to administering study drug
  • No drugs known to prolong the QT interval during and for 24 hours after study drug
  • No concurrent therapy with known CYP3A4 substrates
  • No other concurrent investigational agents
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005973
 
CDR0000067960, MDA-ID-99304, NCI-671
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Vassiliki A. Papadimitrakopoulou, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP